EMP EXEMPT MEDICINAL PRODUCTS LI
⚠️ Moderate Risk
FEI: 3017871718 • Drogheda • IRELAND
FEI Number
3017871718
Location
Drogheda
Country
IRELANDAddress
Unit 3, Boyne Business P, Drogheda, , Ireland
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/27/2021 | 60TCA15NALTREXONE (ANTAGONIST) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is EMP EXEMPT MEDICINAL PRODUCTS LI's FDA import refusal history?
EMP EXEMPT MEDICINAL PRODUCTS LI (FEI: 3017871718) has 1 FDA import refusal record(s) in our database, spanning from 1/27/2021 to 1/27/2021.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. EMP EXEMPT MEDICINAL PRODUCTS LI's FEI number is 3017871718.
What types of violations has EMP EXEMPT MEDICINAL PRODUCTS LI received?
EMP EXEMPT MEDICINAL PRODUCTS LI has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about EMP EXEMPT MEDICINAL PRODUCTS LI come from?
All FDA import refusal data for EMP EXEMPT MEDICINAL PRODUCTS LI is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.